Waters launches XBridge Premier GTx BEH SEC columns for gene therapy applications

Waters Corporation introduced the first in a new line of size exclusion chromatography (SEC) columns aimed at improving the analysis while lowering the cost of gene therapies, specifically adeno-associated viral (AAV) vectors. The new Waters^™ XBridge^™ Premier GTx BEH^™ SEC columns doubles the speed of measuring the potency and safety of AAVs. Combining the columns with light scattering technologies from its Wyatt Technology portfolio deepens the level of information acquired from a single experiment and optimizes the manufacturing of these novel gene delivery vehicles.

"We are witnessing a revolution in medicine thanks to gene therapies like AAVs," said Erin Chambers, Vice President, Consumables and Lab Automation, Waters Corporation. "A small quantity of a gene therapy, such as one of the best-selling eye treatments, can retail for more than $400,000 per eye. This makes it imperative that process and formulation development tests measure multiple attributes of the drug at once while consuming as little of it as possible. It's why Waters' low adsorption, high-efficiency XBridge Premier GTx BEH SEC columns are such a good choice for process development, formulation studies, regulatory filing support, along with ongoing process monitoring as well as quality control."

Avid Bioservices (Tustin, California) received early access to the XBridge Premier GTx columns.

The XBridge Premier GTx BEH SEC columns significantly widened the dynamic range of our SEC platform method for AAV aggregate analysis. It is now possible to analyze AAV aggregates from small amounts of sample with an HPLC method that is up to five times faster than conventional SEC methods for this application. This will help us expedite study timelines and reduce overall costs."

Kilian Witzel, Senior Scientist, Analytical Development Viral Vectors, Avid Bioservices, Inc

AAVs are modified viruses made in bioreactors by living cells and are the number one vehicle for carrying therapeutic genes into human cells. Waters scientists have developed a fast and efficient multi-attribute quantification method of characterizing AAVs that features the following Waters products:

• ACQUITY™ Premier UPLC^™ Systems or Arc^™ Premier HPLC Systems
• XBridge Premier GTx BEH SEC 450Å 2.5 μm columns
• Arc Premier 2489 UV/Visible detector or 2998 photodiode array detector
• Wyatt^™ DAWN^™ multi-angle light scattering detector
• Wyatt Optilab^™ differential refractive index detector

XBridge Premier GTx BEH SEC columns are now available worldwide from Waters.